To prove the usefulness of clinical relapse prediction in patients with ulcerative colitis using computer aided diagnosis system(UC-CAD) with ultra-magnification endoscope.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

the difference in clinical relapse rate according to the diagnosis of UC-CAD.

Key secondary outcomes

1. The differences in clinical relapse rate by extent of disease according to the diagnosis according to UC-CAD 2. The differences in clinical relapse rate according to the diagnosis according to endoscopists. 3. Time required to diagnose UC-CAD 4. Cecal success rate 5. Cecal insertion success time

Base

Study type

Observational

Study design

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who have been diagnosed with establised ulcerative colitis.Patients who perform colonoscopy following to their clinical needs. Patients with clinical remission (partial Mayo Score of 0 or 1).Patients not using Prednisolone within half a year.Patients who have not received radiation therapy for the abdominal or pelvis.

Key exclusion criteria

Patients who have been denied participation in this study
Patients who could not follow up at the end of the study or until relapse

Target sample size

150

Research contact person

Name of lead principal investigator

1st name

Yasuharu

Middle name

Last name

Maeda

Organization

Showa University Northern Yokohama Hospital

Division name

Digestive Disease Center

Zip code

224-8503

Address

Yokohama

TEL

+81459497000

Email

wakamura92@gmail.com

Public contact

Name of contact person

1st name

Yasuharu

Middle name

Last name

Maeda

Organization

Showa University Northern Yokohama Hospital

Division name

Digestive Disease Center

Zip code

224-8503

Address

Yokohama

TEL

+81459497000

Homepage URL

Email

yasuharumaeda610@hotmail.com

Sponsor

Institute

Digestive Disease Center,Showa University Northern Yokohama Hospital

Institute

Department

Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Showa University Northern Yokohama Hospital Digestive Disease Center

Address

35-1 Chigasakichuo Tudukiku Yokohama

Tel

+81459497000

Email

irb02syh@ofc.showa-u.ac.jp

Secondary IDs

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Institutions

昭和大学横浜市北部病院(神奈川県)

Other administrative information

Date of disclosure of the study information

2019

Year

05

Month

07

Day

Related information

URL releasing protocol

Publication of results

Unpublished

Result

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Preinitiation

Date of protocol fixation

2019

Year

04

Month

05

Day

Date of IRB

Anticipated trial start date

2019

Year

05

Month

08

Day

Last follow-up date

2020

Year

11

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

We compare and examine the relapse rate according to the diagnosis of the automatic diagnosis system using the super-magnification endoscope. The observation period is 6 months from the final patient recruitment. Diagnosis of UC-CAD of each localization is performed by majority rule. The diagnosis of UC-CAD in each patient is the diagnosis of the most intense localization of inflammation. The definition of clinical relapse is treatment intervention for partial Mayo Score 3 or higher or symptom exacerbation.